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RecruitingPHASE2INTERVENTIONAL

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

This research study is investigating a new medication called calderasib, for people with advanced solid cancers. These are cancers that have spread or cannot be removed by surgery, and have a specific genetic change known as the KRAS G12C mutation. The study aims to find out if calderasib, given by itself or together with another existing cancer medicine called cetuximab, can help shrink or get rid of these types of cancers. Researchers will compare how well both treatment options work. They also want to understand how safe these treatments are and if people can tolerate taking them. This is an important step to find new ways to treat these particular cancers.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
150
Start
04 Dec 2025
Estimated completion
09 Apr 2032

What is this study about?

This study is looking into new ways to treat certain advanced cancers. 'Advanced' means the cancer has grown or spread, and 'solid tumors' are lumps of cancer cells, not like blood cancers. The study focuses on people whose advanced solid cancers have a specific change in their genes, called a KRAS G12C mutation. This change can make cancers harder to treat, so finding new medicines for it is very important.

Researchers want to see how a new medicine, calderasib, works. They are testing it in two ways: some people will receive calderasib on its own, and others will receive calderasib combined with another existing cancer medicine called cetuximab. The main goal is to see if these treatments can make the cancer shrink or even disappear. They will also look at how much the cancer responds in each group.

Another very important part of the study is to understand the safety of these treatments. This means looking at any side effects people might experience and how well their body handles the new medicines. By carefully studying these things, doctors can learn more about how to best use calderasib to help people with these specific advanced cancers in the future.

Key takeaways

  • This study explores a potential new treatment (calderasib) for specific advanced cancers.
  • It targets cancers with a specific genetic change called the KRAS G12C mutation.
  • People will receive calderasib alone or with cetuximab.
  • The study aims to see if the treatments shrink cancer and to check their safety.
  • Participation involves regular hospital visits for treatments and health checks.

Who may be eligible?

To join this study, people generally need to be at least 18 years old and have an advanced solid cancer that has either spread or cannot be removed by surgery. This cancer shouldn't be a type of bowel cancer. Importantly, their cancer must have progressed despite having received standard treatments already, and a test must show that their cancer has a specific genetic change called the KRAS G12C mutation.

There are also some reasons why someone might not be able to join. For example, if they have serious heart problems that are not controlled, or if they have other cancers that are growing or have needed recent treatment. People with active infections needing strong medicines, or cancers that have spread to their brain, would also not be able to participate. Also, if someone has not fully recovered from recent major surgery, they might not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am 18 years old or older.
  2. I have an advanced solid cancer that is not bowel cancer.
  3. My cancer has progressed after standard treatments.
  4. My cancer has been tested and found to have the KRAS G12C genetic change.
  5. I do not have serious uncontrolled heart conditions.
  6. I generally feel well enough and don't have other active serious illnesses that would prevent me from joining.
Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive either calderasib alone or calderasib with cetuximab, depending on which group you're assigned to. This will involve regular visits to the hospital or clinic for your medication and various tests. These tests might include blood tests, scans (like CT or MRI) to check your cancer, and physical examinations. The doctors and nurses will closely monitor your health and any side effects you might experience. They’ll also ask you about how you're feeling and any symptoms you have. The exact number of visits and the full duration of your participation will be explained in detail by the study team, but it will involve ongoing assessment and treatment for as long as the treatment is beneficial or until side effects make it necessary to stop.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new treatment that might help when other standard treatments haven't worked or have stopped working. However, there are also potential risks involved, as the new medicine, calderasib, is still being studied and its full side effects are not yet completely known. You might experience side effects, some of which could be serious. The study team will explain all known risks to you. Remember, joining is completely voluntary, and you have the absolute right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (58)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Greater Baltimore Medical Center ( Site 1104)
    Verified postcode
    Baltimore, United States· Recruiting
  • START Midwest ( Site 1103)
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Comprehensive Cancer Centers of Nevada ( Site 1109)
    Verified postcode
    Las Vegas, United States· Recruiting
  • Rutgers Cancer Institute of New Jersey ( Site 1100)
    Verified postcode
    New Brunswick, United States· Recruiting
  • START Mountain Region ( Site 1106)
    Verified postcode
    West Valley City, United States· Recruiting
  • Virginia Cancer Specialists ( Site 1102)
    Verified postcode
    Fairfax, United States· Recruiting
  • Prince of Wales Hospital-Medical Oncology ( Site 1003)
    Verified postcode
    Randwick, Australia· Recruiting
  • Westmead Hospital ( Site 1000)
    Verified postcode
    Westmead, Australia· Recruiting
  • Epworth Freemasons ( Site 1004)
    Verified postcode
    Melbourne, Australia· Recruiting
  • Jewish General Hospital-CRU ( Site 2900)
    Verified postcode
    Montreal, Canada· Recruiting
  • FALP ( Site 1200)
    Verified postcode
    Santiago, Chile· Recruiting
  • Centro de Oncología de Precisión ( Site 1202)
    Verified postcode
    Santiago, Chile· Recruiting

Common questions

What is a 'solid tumor'?

A solid tumor is a lump or mass of cancer cells that forms in most parts of the body, unlike blood cancers like leukaemia.

What is the 'KRAS G12C mutation'?

This is a specific change in the DNA of your cancer cells. Finding this change helps doctors understand more about your cancer and if certain medicines might work.

What does 'advanced' cancer mean in this study?

It means the cancer has either spread to other parts of the body (metastatic) or has grown in its original location so much that it cannot be completely removed by surgery (locally advanced unresectable).

Will I know if I'm getting calderasib alone or with cetuximab?

Yes, in this type of study, you and your doctors will know which treatment you are receiving, as it's not a 'blinded' study.

Can I stop participating in the study if I change my mind?

Absolutely. You can choose to leave the study at any point, and it will not affect your relationship with your doctor or the quality of your future medical care.

How to find out more

Toll Free Number

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Study of Calderasib (MK-1084) in People With Adva…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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